NCT03312738 - A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor | Biotech Hunter

Enrollment

159

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

April 25, 2022

Study Completion Date

April 25, 2022

Conditions

Advanced Breast Cancer

Interventions

DRUG

Everolimus

Everolimus was formulated as tablets of 5 mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) was administered in a blinded manner by continuous oral daily dosing.

DRUG

Exemestane

Commercially available exemestane was supplied as 25 mg tablets. Exemestane was administered as continuous oral daily dose of 25 mg tablets.

DRUG

Everolimus Placebo

Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) was administered in a blinded manner by continuous oral daily dosing.

Trial Locations (15)

100036

Novartis Investigative Site, Beijing

150081

Novartis Investigative Site, Harbin

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

210009

Novartis Investigative Site, Nanjing

266000

Novartis Investigative Site, Qingdao

300060

Novartis Investigative Site, Tianjin

310022

Novartis Investigative Site, Hangzhou

400016

Novartis Investigative Site, Chongqing

430000

Novartis Investigative Site, Wuhan

430022

Novartis Investigative Site, Wuhan

510000

Novartis Investigative Site, Guangzhou

510060

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

610072

Novartis Investigative Site, Chengdu